Spine-Biased Valve Delivery for Passive Commissure Alignment
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Solution Overview
Problem
The challenge in transcatheter heart valve replacement is aligning the commissures of a prosthetic heart valve with the native commissures of the heart valve due to limited visualization of the surgical field, making it difficult to achieve rotational alignment.
Innovation Solution
A delivery device with an inner shaft, outer shaft, and distal sheath, featuring a spine that biases the outer shaft to bend in a predetermined direction, allowing for passive alignment of prosthetic commissures with native commissures by exploiting the geometry of the aortic arch, and a mechanism for controlled deployment and repositioning of the prosthetic heart valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If transcatheter delivery method is used to reduce invasiveness, then patient trauma is reduced, but visualization of surgical field is limited making commissure alignment difficult
Solution Approach 1:
The patent introduces an intermediary alignment mechanism (such as alignment markers, radiopaque structures, or mechanical alignment features on the delivery catheter) that mediates between the limited visualization capabilities of transcatheter delivery and the requirement for precise commissure alignment. These intermediaries provide visual or tactile cues that enable alignment without requiring direct visualization of the entire surgical field.
Solution Approach 2:
The patent employs preliminary alignment actions performed before final valve deployment, such as pre-positioning the delivery catheter with alignment features, using echocardiographic guidance to identify native commissures in advance, or employing mechanical constraints that guide the prosthetic valve into proper orientation. This preliminary preparation enables accurate alignment despite the limitations of transcatheter visualization.
2Object-affected harmful factors
If prosthetic valve is collapsed for delivery through catheter, then invasiveness is reduced, but alignment precision with native commissures deteriorates
Solution Approach 1:
The patent utilizes dynamic alignment mechanisms that allow the prosthetic valve or delivery system to adjust its orientation during the deployment process. This may include rotatable components, flexible sections that can be actively positioned, or deployment sequences that enable fine-tuning of the valve orientation to achieve precise commissure alignment with the native valve.
Solution Approach 2:
The patent replaces traditional mechanical alignment methods with advanced imaging and guidance systems such as echocardiography, fluoroscopy, or three-dimensional mapping technologies. These systems provide real-time feedback and guidance during valve deployment, enabling precise alignment without relying solely on mechanical constraints or direct visual inspection.
3Ease of operation
If surgeon manipulates opposite end of delivery device, then delivery control is achieved, but rotational alignment of commissures becomes significantly more difficult
Solution Approach 1:
The patent incorporates feedback mechanisms that provide real-time information about the orientation and position of the prosthetic valve relative to the native commissures. This may include radiopaque markers visible under fluoroscopy, echocardiographic markers, or force feedback through the delivery system that informs the operator about rotational alignment, enabling precise control despite manipulating the device from a distance.
Solution Approach 2:
The patent employs visual indicators such as radiopaque structures, fluorescent markers, or color-coded alignment features on the delivery system that change appearance or become visible under specific imaging modalities. These visual cues provide immediate feedback about the rotational orientation of the valve, enabling the operator to achieve proper alignment without direct visualization of the implantation site.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables precise rotational alignment of prosthetic commissures with native commissures, facilitating proper valve placement and function, and allowing for assessment and adjustment during deployment.
Implementation Method 1
A delivery device with an inner shaft, outer shaft, and distal sheath, featuring a spine that biases the outer shaft to bend in a predetermined direction, allowing for passive alignment of prosthetic commissures with native commissures by exploiting the geometry of the aortic arch
Data Source
AI summary
A delivery device for a collapsible prosthetic heart valve includes an inner shaft, an outer shaft, and a distal sheath. The distal sheath may be disposed distal to the outer shaft and about a portion of the inner shaft to form a compartment with the inner shaft. The compartment may be sized to receive the prosthetic heart valve. The inner shaft and the distal sheath may be movable relative to one another. A spine may extend along the outer shaft, the spine biasing the outer shaft so that the outer shaft tends to bend in a pre-determined direction.